VALIDA project: Validation of allergy in vitro diagnostics assays (Tools and recommendations for the assessment of in vitro tests in the diagnosis of allergy)

Abstract

In vitro allergen-specific immunoglobulin E (IgE) detection and quantification tests are routinely performed in clinical laboratories to diagnose patients with a suspected allergy. Numerous commercial assays are available to test for allergies, but the results can vary widely, thereby influencing both diagnosis and treatment. Given the challenges posed by differences in the various assays for in vitro determination of specific IgE, a group of experts has compiled in a document a series of recommendations on the implications that the use of a certain in vitro technique may have and the impact on the management of the allergic patient that the differences between the various techniques represent. The reading and analysis of this consensus document will help to understand the implications of the change of in vitro diagnostic method in the management of the patient with allergy, in the quality of life and in the socioeconomic costs associated with the disease.

Integration of in vitro allergy test results and ratio analysis for the diagnosis and treatment of allergic patients (INTEGRA)

“…In addition to measuring and evaluating the clinical significance of each variable (sIgE and tIgE) separately, analysing the relationship between them (ratio analysis) can also provide valuable information to improve their clinical interpretation 5 . Similarly, allergen‐sIgE can be compared to the we‐sIgE or c‐sIgE 6 …”

“…Other complementary tests may also be necessary. Serum‐sIgE tests are designed to detect and measure the concentration of IgE to a specific allergen 6 . Positive results in sIgE tests indicate the culprit allergens and are helpful to recommend avoidance measures (which often alleviate symptoms) 8 and for diagnostic purposes.…”

“…5 Similarly, allergen-sIgE can be compared to the we-sIgE or c-sIgE. 6 For these purposes, two ratios have been proposed:…”

Qualitative and quantitative comparison of allergen component-specific to birch and grass analyzed by ImmunoCAP assay and Euroline immunoblot test

“…The method is gaining increasing clinical awareness [3,4]. However, when looking at scientific publications in the Medline database published before 2020, ImmunoCAP heavily outweighs Euroline with 600 publications compared to 7 articles about Euroline [2].…”

“…Various methods exist for testing allergen-specific IgE antibodies and their results can vary greatly, thereby affecting both the diagnosis and treatment of allergic diseases [2]. It is not easy to compare the results of different test systems with each other as there are differences in the development of the methods.…”